1. Field of the Invention
This invention relates in general to certain new and useful improvements in needle devices, and more particularly, to needle devices for use with subcutaneous access catheters and which needle devices include a means to temporarily affix the needle device to the skin of the patient.
2. Brief Description of the Prior Art
In many surgical procedures, it is necessary to provide an internal catheter or so-called "subcutaneous catheter" and which has access to some organ of the body, as for example, the heart. Thus, and in the case of a cardiac catheter, one end may be introduced directly into a ventrical of the heart. The opposite end of the catheter tube, which may be a conventional silicone rubber tube, is connected to a small subcutaneous implanted hat-shape device which contains an internal reservoir. The reservoir may be filled with an intravenous solution or otherwise with medications for the heart or other organ or the like. It is necessary to periodically introduce additional midiciments or fluids into this internal chamber. Moreover, the introduction may occur on a long term basis where the needle would have to penetrate into the chamber and yet protrude from the body for a period of time.
The use of the conventional needle for introducing fluids into the sealed chamber of the subcutaneous catheter assembly creates several problems in that the needle must be affixed to the skin of the patient to prevent any rupture and tear of the patients skin or to prevent any dislodgment as a result of movement of the patient or inadvertent contact with the needle. Generally, the nurses in the hospital or other environment attempt to support the needle by surgical tape. Moreover, gauze may be placed around the needle and then the needle is taped to the patients skin to reduce the amount of movement of the needle. In many cases, it is necessary for the patient to remain perfectly still.
This procedure of implanting a needle results in a potential danger to the patient in that someone could inadvertently contact the needle and push the same thereby rupturing the skin of the patient, if not damaging the subcutaneous catheter. Moreover, it presents a constant hazard in that the nurses or others who attend to the patient must be frequently cautious about inadvertent contact with the needle.
In an attempt to obviate this problem, there have been several proposed "right-angle" needles. That is, needles which have a shank to extend directly into the patients arm, generally perpendicular to the surface of the skin as well as an arm located at right angles thereto. However, here again, it is necessary to secure the needle in some fashion so that the right-angled arm does not move or in effect pivot about the patients skin through rotation of the vertical shank. Here again, the nurses and other attendants have attempted to use surgical tape in order to secure the needle to the patients body. Nevertheless, this means of securement has not been effective inasmuch as the needle is usually formed of a stainless steel and the surgical tape does not efficiently adhesively adhere to the arm of the patient and moreover does not effectively hold the same in a secure position on the skin of the user.
There are several commercially available needles which contain an elongate relatively straight shank and a pair of flanges or similar members secured to and extending outwardly from the needle. Needles of this type are typically referred to as "scalp vein" needles. The flanges on these needles are designed to receive the surgical tape or the like for purposes of securing the tape to the users body. However, the scalp vein needle is adapted to puncture the skin at a very slight angle relative to the skin and, in a manner almost parallel to the surface of the skin. Thus, the use of the flanges on the scalp vein needle has been moderately effective. However, and here again, their effectiveness resides in the fact that the shank of the needle extends into the skin at a very shallow angle relative to the skin.
U.S. Pat. No. 4,380,234 to Kamen discloses an infusion needle attachment which is adapted to effectively guide the unseen portion of a needle into position on the body of the recipient. In this way, the user of the needle is able to judge the desired location at which point the needle should make a physical contact preparatory to subcutaneous administration. The device is not designed for subcutaneous access in the body of the user.
Heretofore, there has not been any effective device for securely holding a needle used with a subcutaneous catheter assembly in a secured position.